MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. FREEDOM DRIVER; ARTIFICIAL HEART

Device Problems False Alarm (1013); No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2016

Event Type  malfunction  

Event Description

A freedom driver stopped without audible or visual alarms alerting.The patient's wife awoke to a silent freedom driver - the wife changed the patient to a back-up freedom driver provided per hospital protocol.Subsequently, the patient's wife accidently hit the driver with her foot and the driver experienced a fault alarm.Since there was no additional back-up driver 㠅ms was called and the patient was airlifted to the hospital.Manufacturer response for syncardia freedom driver, (brand not provided) (per site reporter): been in contact with us frequently.

• Brand Name: FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tuscon AZ 85713
• MDR Report Key: 6030359
• MDR Text Key: 57484775
• Report Number: 6030359
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2016
• Event Location: Home
• Date Report to Manufacturer: 10/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TOTAL ARTIFICIAL HEART